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Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT04217213
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Han Yuan, Xuzhou Medical University

Brief Summary:
This project intends to investigate the effects of intercostal nerve block with ropivacaine combined with mecobalamin on chronic post-surgical pain (CPSP) in thoracic postoperative patients. Related clinical characteristics of postoperative chronic pain. The results of the study provide clinicians with a simple and inexpensive new method of preventing CPSP, in order to prevent the occurrence of CPSP and reduce the incidence of CPSP, thereby reducing CPSP to patients and their families, hospitals. And public resources.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: Intercostal nerve block Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Intercostal Nerve Block With Ropivacaine Combined With Mecobalamine on Chronic Pain After Thoracic Surgery -- a Single-center Randomized, Double-blind Controlled Trial
Estimated Study Start Date : January 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: ropivacaine combined with mecobalamine
Intercostal nerve block with 0.5% ropivacaine combined with mecobalamine (0.5mg).
Procedure: Intercostal nerve block
In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.

Active Comparator: ropivacaine
Intercostal nerve block with 0.5% ropivacaine alone.
Procedure: Intercostal nerve block
In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.




Primary Outcome Measures :
  1. Incidence of chronic pain after chest surgery [ Time Frame: At the 3rd month after surgery ]
    The incidence of chronic pain after chest surgery was measured by NRS(numeric rating scales) at the 3rd month after surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".


Secondary Outcome Measures :
  1. The incidence of acute pain after chest surgery [ Time Frame: 24 to 72 hours after surgery ]
    An NRS score was performed 24 to 72 hours after surgery to determine the incidence of acute pain after thoracic surgery.For pain evaluation,we used the 11 point numeric rating scale(NRS),where an NRS scores of 0 represented "no pain" and a score of 10 represented "worst pain imaginable".

  2. Incidence of postoperative neuropathic pain [ Time Frame: At the 3rd month after surgery ]
    The incidence of neuropathic pain was measured by DN4 scale at the 3rd month after surgery.Douleur Neuropathique 4 (DN4) is a screening questionnaire to help identify neuropathic pain (NP) in clinical practice and research,where a DN4 scores greater than or equal to 4 represented the patients had "postoperative neuropathic pain".

  3. Incidence of other postoperative complications [ Time Frame: At the 3rd month after surgery ]
    Postoperative complications included that pulmonary complications, delirium, intestinal obstruction, pulmonary embolism, acute respiratory failure, acute renal failure, incision infection, cerebrovascular accident and other complications related to surgery.

  4. Incidence of readmission within 30 days after surgery [ Time Frame: At the 30 days after surgery ]
    The incidence and the reason of readmission within 30 days after surgery was obtained through postoperative follow-up.

  5. Incidence of death within 30 days after surgery [ Time Frame: At the 30 days after surgery ]
    The incidence and the reason of death within 30 days after surgery was obtained through postoperative follow-up

  6. Length of stay [ Time Frame: At the 3rd month after surgery ]
    The total length of hospital stay.

  7. Cost of stay [ Time Frame: At the 3rd month after surgery ]
    The total cost of hospital stay.

  8. icu length of stay [ Time Frame: At the 3rd month after surgery ]
    The number of hours of postoperative stay in ICU.

  9. Incidence of secondary operation [ Time Frame: At the 3rd month after surgery ]
    Whether the patient has a second operation and the reason and the incidence of this operation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥18 years old, conscious;
  2. ASA class Ⅰ ~ Ⅲ;
  3. Thoracoscopic lobectomy was proposed;
  4. The han nationality;
  5. Native speaker of Chinese;
  6. Agree to participate in this study and sign the informed consent.

Exclusion Criteria:

  1. Patients allergic to meccobalamin or ropivacaine;
  2. Patients with previous history of chest surgery;
  3. Patients with tumor invasion of chest wall, abscess, tumor intercostal neuropathy or pathological rib fracture;
  4. Patients with a history of analgesic addiction or abuse, epilepsy, one or other neurological disease;
  5. Diabetic patients;
  6. Patients who need other drugs for pain relief but have not completed treatment or have completed treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217213


Locations
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China, Jiangsu
Department of Anesthesiology of the Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 225000
Sponsors and Collaborators
Xuzhou Medical University
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Responsible Party: Han Yuan, associate chief physician, Xuzhou Medical University
ClinicalTrials.gov Identifier: NCT04217213    
Other Study ID Numbers: XYFY2019-KL169-01
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms